FEops HEARTguide Simulation Application
K-Number: K250635 · 2025-11-25
ApplicantFeops NV
Decision Date2025-11-25
Product CodeQQI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FEops HEARTguide Simulation Application is a medical device manufactured by Feops NV. It received FDA 510(k) clearance on 2025-11-25 under approval number K250635. The device is classified under product code QQI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FEops HEARTguide Simulation Application?
FEops HEARTguide Simulation Application is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Feops NV. The 510(k) number is K250635.
When was FEops HEARTguide Simulation Application approved by the FDA?
FEops HEARTguide Simulation Application received FDA 510(k) clearance on 2025-11-25, under approval number K250635.
What company makes FEops HEARTguide Simulation Application?
FEops HEARTguide Simulation Application is manufactured by Feops NV.
What is the FDA product code for FEops HEARTguide Simulation Application?
The FDA product code for FEops HEARTguide Simulation Application is QQI.
Related Clinical Trials
Other Devices by Feops NV
Related Devices (Code: QQI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.